This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.

Device Description

The FT-810R with a remote controller is a self-adhesive TENS device with 15 adjustable intensity level for pain relief. Moreover, it also provides a heat function which can be used in conjunction with the TENS function. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective non-pharmacological method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS self-treatment regime.

TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear and must be replaced when they stop providing sufficient contact or the main device no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.

AI/ML Overview

The provided text is a 510(k) summary for the Hivox Biotek Inc. Heating TENS (FT-810R) device. It details the device's characteristics, its comparison to predicate devices, and the non-clinical tests performed to demonstrate substantial equivalence. However, it explicitly states that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, I cannot provide information on acceptance criteria based on human performance, nor can I describe a study that proves the device meets such criteria, because no clinical efficacy or human performance studies were conducted or presented for this 510(k) clearance. The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices through engineering and safety testing.

The document focuses on non-clinical testing to ensure the device meets predefined acceptance criteria for safety and performance, primarily in comparison to its predicate devices.

Here's an analysis of the provided information, addressing your points where possible, and explicitly stating where information is not available:

1. A table of acceptance criteria and the reported device performance

The document mentions that "All the test results demonstrate the subject device, Heating TENS (FT-810R), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device." However, it does not explicitly list the specific quantitative acceptance criteria or the reported performance for each criterion in a consolidated table. Instead, it lists the types of non-clinical tests performed and implies that the device passed them by stating it "meets the requirements."

The "Table 1 – Comparison to Predicate Devices and Reference Device" does show comparisons of various technical specifications (e.g., maximum temperatureetting, output voltage, current, pulse width, frequency, maximum phase charge, maximum current density, maximum power density, etc.). While these are comparative performance metrics, they are not presented as explicit "acceptance criteria" with a target value + achieved value in the way you might see for clinical performance. The acceptance here is that it falls within a similar, safe, and effective range as the predicate devices.

For example, we can infer acceptance based on the comparison table:

Comparison Item	Implied Acceptance Criterion	Reported Device Performance (FT-810R)
Functional Equivalence	The device's function and design (electrical stimulation and heat) should be comparable to predicate devices.	Identical to predicate device.
Power Source	Must use a similar power source to predicate devices.	3.7 V Lithium-ion battery (identical to Predicate #2, similar to Predicate #1 "Rechargeable battery").
Maximum Temperature Setting	Must operate at or below predicate device temperature settings for safety (e.g., 43℃).	43℃ (Identical to predicate device).
Safety Standards Compliance	Must comply with relevant electrical safety, EMC, usability, and biocompatibility standards (e.g., ANSI/AAMI ES60601-1, IEC 60601 series, ISO 10993 series).	Compliant with ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-5, ISO 10993-10, 21 CFR 898.
Output Waveform	Should be similar to predicate devices (e.g., Biphasic, Symmetrical, Rectangular shape).	Biphasic, Symmetrical, Rectangular (identical to predicate device).
Maximum Output Voltage (@ 500 Ω)	Voltage profile should be within a safe and effective range comparable to predicate devices.	72 Vp-p (@ 500 Ω). (Predicate #1: 100 Vp-p, Predicate #2: 72 Vp-p. "No significant differences would raise concern in safety or effectiveness").
Maximum Output Current (@ 500 Ω)	Current profile should be within a safe and effective range comparable to predicate devices.	144 mAp-p (@ 500 Ω). (Predicate #1: 200 mAp-p, Predicate #2: 144 mAp-p. "No significant differences would raise concern in safety or effectiveness").
Maximum Phase Charge (@ 500 Ω)	Safety margin relative to predicate devices.	21.6 µC (@ 500 Ω). ("much lower than Predicate device #1 [45 µC]. The differences would not raise concern in safety or effectiveness from predicate device").
Maximum Averaged Current (@ 500 Ω)	Safety margin relative to predicate devices.	9.04 mA (@ 500 Ω). ("No significant differences would raise concern in safety or effectiveness").
Maximum Current Density (@ 500 Ω)	Max current density should be below safety limits (e.g., 2mA/cm² per IEC 60601-2-10).	1.01 mA/cm² (@ 500 Ω). ("lower than 2mA/cm² which meets the requirement of IEC 60601-2-10").
Maximum Power Density (@ 500 Ω)	Max power density should be below safety limits (e.g., 0.25 W/cm²).	0.055 W/cm² (@ 500 Ω). ("< 0.25W/cm²").
Wireless Communication	If applicable, wireless features should meet relevant standards (e.g., FCC Part 15).	Meets FCC Part 15 (identical to reference device).
Shelf Life	Device maintains performance over its defined shelf life.	(Passed ASTM F1980-16, results not detailed).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: The document does not specify a "sample size" in terms of patient data or clinical images, as no clinical studies were performed. The "test set" here refers to the device units themselves that underwent non-clinical testing. The number of physical units tested is not specified (e.g., "N=3 devices passed electrical safety testing").
Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Hivox Biotek Inc.) or their contracted labs, primarily in Taiwan (R.O.C.) as indicated by their address. The studies conducted were non-clinical performance and safety tests, not retrospective or prospective patient data studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as there was no test set involving human data or expert review for establishing "ground truth" (e.g., diagnostic labels, disease presence/absence). The ground truth for the non-clinical tests would be the established engineering and safety standards (e.g., IEC 60601 series, ISO 10993 series).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as no human expert review or adjudication of data (e.g., medical images) was involved in this 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. The device cleared is a hardware-based TENS/EMS device with heating function, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable as the device is not an algorithm for diagnosis or interpretation. Its performance is evaluated based on its physical, electrical, and thermal outputs meeting specified safety and performance requirements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests was adherence to recognized consensus standards and/or guidance documents (e.g., ASTM F1980-16 for shelf life, ISO 10993 for biocompatibility, IEC 62304 for software validation, ANSI/AAMI ES60601-1 and related IEC 60601 series for electrical safety and EMC). These standards define the acceptable limits and performance characteristics for such medical devices.

8. The sample size for the training set

This is not applicable as the device is not an AI/Machine Learning algorithm that requires a "training set" of data.

9. How the ground truth for the training set was established

This is not applicable as there was no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

May 13, 2023

Hivox Biotek Inc. Shaun Hsu Regulatory Affairs Specialist 5F., No. 123, Xingde Rd. Sanchong Dist. New Taipei City, 24158 Taiwan

Re: K223308

Trade/Device Name: Heating Tens/ems, Ft-810r Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, IRT Dated: January 17, 2023 Received: April 14, 2023

Dear Shaun Hsu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Pamela D. Scott -S

Pamela D. Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K223308

Device Name Heating TENS (FT-810R)

Indications for Use (Describe)

This home used device is designed to be used for adult and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household work activities. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. Type of Submission Traditional

2. Date of Summary	October 21, 2022
3. Submitter	HIVOX BIOTEK INC.
Address:	5F., No. 123, Xingde Rd., Sanchong Dist.,New Taipei City 24158, Taiwan, R.O.C.
Phone:	+886-2-8511-2668
Fax:	+886-2-8511-2669
Contact:	Shaun Hsu (shaun.hsu@hivox-biotek.com)

4. Identification of the Subject Device

Proprietary Name:	Heating TENS
Model:	FT-810R
Regulation Description:	Transcutaneous electrical nerve stimulator for pain relief
Product Code:	NUH
Regulation Number:	21 CFR 882.5890
Device Class:	II

5. Identification of the Predicate Device #1

510(k) Number:	K203574
Manufacturer:	HIVOX BIOTEK INC.
Proprietary Name:	HIVOX OTC Electrical Stimulator
Model:	EM59-1
Regulatory Description:	1) Transcutaneous electrical nerve stimulator for pain relief2) Power heating pad
Product Code:	NUH, IRT
Regulatory Number:	1) 21 CFR 882.58902) 21 CFR 890.5740
Device Class:	II

6. Identification of the Predicate Device #2

510(k) Number:	K211403
Manufacturer:	HIVOX BIOTEK INC.
Proprietary Name:	HIVOX OTC Electrical Stimulator
Model:	FT610-B
Regulatory Description:	Transcutaneous electrical nerve stimulator for pain relie
Product Code:	NUH

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Regulatory Number: 21 CFR 882.5890 Device Class: II

7. Identification of the Reference Device

510(k) Number:	K163393
Manufacturer:	Hi-Dow International, Inc.
Proprietary Name:	Hi-Dow Wireless TENS/EMS
Model:	HD-5N
Regulatory Description:	Transcutaneous electrical nerve stimulator for pain relief
Product Code:	NUH, NGX
Regulatory Number:	21 CFR 882.5890
Device Class:	II

8. Device Description

9. Intended Use / Indications for Use of the Device

10. Non-clinical Testing

A series of safety and performance tests, as follows, were conducted on the subject

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device in accordance with FDA recognized consensus standards and/or guidance:

Shelf life (ASTM F1980-16)
Biocompatibility (ISO 10993-1 Edition 5.0, ISO 10993-5 Edition 3.0 and ISO 10993-10 Edition 3.0)
Software validation (IEC 62304 Edition 1.1)
Electromagnetic compatibility and electrical safety (ANSI/AAMI ES60601-1:2015/(R)2012, IEC 60601-1-2 Edition 4.0, IEC 60601-1-11 Edition 2.0 and IEC 60601-2-10 Edition 2.1)
Function test (Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 9, 1999)
Usability test (IEC 60601-1-6 Edition 3.2 and IEC 62366-1 Edition 1.1)
Function Validation (Attachment 19-1 Performance Verification Report)
Output Waveform Validation (Guidance Document for Powered Muscle Stimulator 510(K)s. Document issued on: June 8, 1999, Attachment 19-3 Output Waveform Report)
Impedance Validation (Attachment 19-4 Impedance Test Report)

All the test results demonstrate the subject device, Heating TENS (FT-810R), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device.

11. Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

12. Substantial Equivalence Comparison

The subject device, Heating TENS (FT-810R), was compared to the predicate devices and reference device in the table below:

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Traditional 510(k) Section 6 – 510(k) Summary

Table 1 – Comparison to Predicate Devices and Reference Device

Comparison item	Subject device	Predicate device #1	Predicate device #2	Reference device	SubstantialEquivalence Determination
510(k) Number	K223308	K203574	K211403	K163393
Device Name	Heating TENS	HIVOX OTC ElectricalStimulator	HIVOX OTC ElectricalStimulator	Hi-Dow WirelessTENS/EMS	N/A
Model	FT-810R	EM59-1	FT610-B	HD-5N
Manufacturer	HIVOX BIOTEK INC.	HIVOX BIOTEK INC.	HIVOX BIOTEK INC.	Hi-Dow International, Inc.
Intended Use	This home used device isdesigned to be used for adult andfor temporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, upper extremities (arm) andlower extremities (leg) due tostrain from exercise or normalhousehold work activities. Inaddition, it also provides a heatfunction intended to temporarilyrelief of minor aches and pains.	EM59-1:TENS: This function is designed to be used for temporary relief ofpain associated with sore and aching muscles in the shoulder,waist, back, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities.SH: This function is designed to be used for temporary relief ofminor aches and pains.	The FT610-B is designedfor symptomatic relief andmanagement of chronicpain, and for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, neck, upperextremities and lowerextremities due to strainfrom exercise or normalhousehold work activities.	TENS:To be used for thetemporary relief of painassociated with sore oraching muscles in theshoulder, waist, back,upper extremities (arm),and lower extremities (leg)due to strain from exerciseor normal household workactivities.EMS:It is intended for muscleconditioning, used forstimulating musclesincluding abdomen musclesin order to improve orfacilitate muscleperformance.	Subject device implements the sametechnological features as the predicatedevices.We are using the FT610-B to show thatFDA has cleared a TENS with heatingcapability for the same indication for usthat we are seeking for the FT-810R thathas maximum charge per phase of 7.2 $\mu$which is lower than the maximumcharge per phase of the 810R. Theprimary predicate (predicate # 1) has amaximum charger per phase of 45 $\mu$ andhas a heating capability and anindication for use that is identical towhich you are seeking for the 810R.Therefore, because the maximum chargeper phase of the 810R falls between thecharge per phase of the 610-B and theEM59-1 and the 810R has the sameindication for use as the two predicates,The FT-810R is substantially equivalentto the legally marketed predicate.Additionally, reference device used foraddition of wireless.
FDA Product Code	NUH	NUH, IRT	NUH	NUH, NGX	Identical to predicate device #2
Prescription or OTC	OTC	OTC	OTC	OTC	Identical
Power Source(s)	3.7 V Lithium-ion battery	Rechargeable battery	3.7 V Lithium-ion battery	DC 3.7V Lithium Battery	Identical
Function and Design	Electrical stimulationand heat	Electrical stimulationand heat	Electrical stimulationand heat	Electrical stimulation	Identical to predicate device
Heating setting	Low and high	Low and high	Nonadjustable	N/A	Predicate device #2 has nonadjustableheating setting which will staycontinuously 43℃ unless user switch offthe heating function. Hence, the settingdifferences would not raise concern in

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	Comparison item	Subject device	Predicate device #1	Predicate device #2	Reference device	SubstantialEquivalence Determination
						safety or effectiveness from predicatedevice
	Maximum Temperature Setting(°C)	43	43	43	N/A	Identical to predicate device
	Output Pattern of the Heating	Delivers electricalstimulation and heatsimultaneously	· Electrical stimulation only· Heat only· Electrical stimulation + Heat simultaneously	Delivers electricalstimulation and heatsimultaneously	N/A	Identical to predicate device
	Method of Line CurrentIsolation	N/A(internal power source)	N/A(internal power source)	N/A(internal power source)	Two separate devices, anduse independent powersupply system.	Identical to predicate device
	PatientLeakageCurrent	NormalCondition (μΑ)	< 10	< 10	DC: <10 AC: <100	Identical to predicate device #2
		Single FaultCondition (μΑ)	< 50	5.6	< 50	DC: <50 AC: < 500	Identical to predicate device #2
	Number of Output Modes	4	TENS: 15SH: 1	3	4	Mode differences would not raiseconcern in safety or effectiveness frompredicate device
	Number ofoutputChannels	Synchronous orAlternating?	Single channel	2 Synchronous	Single channel	2 Channel Asynchronous	Identical to predicate device #2
		Method ofChannelIsolation	N/A	By electrical circuit and software	N/A	Two separate devices, anduse independent powersupply system.	Identical to predicate device #2
	Regulated Current or RegulatedVoltage?	Current	Regulated current	Regulated current	Regulated Voltage	Identical to predicate device
	Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Yes	Identical
	Automatic Overload Trip?	Yes	Yes	Yes	No	Identical to predicate device
	Automatic No-Load Trip?	Yes	Yes	Yes	No	Identical to predicate device
	Automatic Shut Off?	Yes	Yes	Yes	Yes	Identical
	Patient Override Control?	Yes	Yes	Yes	Yes	Identical
	On/Off Status?	Yes	Yes	Yes	Yes	Identical to predicate device #1
	IndicatorDisplay	Low Battery?	Yes	Yes	Yes	Yes	Identical to predicate device #1
		Voltage/Current Level?	No	No	No	No	Identical to predicate device #1
	Timer Range (minute)	20	5 to 100 minutesadjustable	20	45	Identical to predicate device #2
	Compliant with VoluntaryStandards?	ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10	ES60601-1 IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10	ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10	IEC 60601-1 / ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-10	Identical to predicate device #2
Comparison item	Subject device	Predicate device #1	Predicate device #2	Reference device	SubstantialEquivalence Determination
	ISO 10993-5ISO 10993-10ISO 10993-23		ISO 10993-5ISO 10993-10	ISO 10993-5ISO 10993-10
	Compliant with 21 CFR 898?	Yes	Yes	Yes	Yes	Identical
	Weight (g)	102	Approx. 125(including belt clip and battery)	47	Remote: 62Receiver: 24	Weight differences would not raiseconcern in safety or effectiveness frompredicate device
	Dimensions (mm)[W x H x D]	300 × 100 × 15	Approx. 139 × 66 × 26(including belt clip)	193 × 95 × 15	Remote: 108 × 53 × 15Receiver: Φ57 × 12	Dimension differences would not raiseconcern in safety or effectiveness frompredicate device
	Housing Materials andConstruction	PC/ABS plastic	Plastic (ABS) enclosure	PC/ABS plastic	ABS	Identical to predicate device
	Waveform	Biphasic, Symmetrical	Biphasic	Biphasic, Symmetrical	Pulsed Biphasic	Identical to predicate device
	Shape	Rectangular	Rectangular	Rectangular	Rectangular	Identical
MaximumOutputVoltage(Vp-p, ±10%)	@ 500 Ω	72	100	72	(TENS) MODE 3:48.5V@500Ω(TENS) MODE 4:41.1V@500Ω(EMS) MODE 1:37.9V@500Ω(EMS) MODE 2:46.8V@500Ω	No significant differences would raiseconcern in safety or effectiveness frompredicate device
	@ 2 kΩ	112	180	112	41.1V@500Ω(EMS) MODE 1:37.9V@500Ω
	@ 10 kΩ	120	250	120	37.9V@500Ω(EMS) MODE 2:46.8V@500Ω
MaximumOutputCurrent(mAp-p,±10%)	@ 500 Ω	144	200	144	(TENS) MODE 3:97mA@500Ω(TENS) MODE 4:82.2mA@500Ω(EMS) MODE 1:75.8mA@500Ω(EMS) MODE 2:93.6mA@500Ω	No significant differences would raiseconcern in safety or effectiveness frompredicate device
	@ 2 kΩ	56	90	56	(TENS) MODE 4:82.2mA@500Ω(EMS) MODE 1:75.8mA@500Ω
	@ 10 kΩ	12	25	12	(EMS) MODE 1:75.8mA@500Ω(EMS) MODE 2:93.6mA@500Ω
	Pulse Width (µs)	200 - 400	50 to 450	100	(TENS) MODE 3:Continuous(TENS) MODE 4: 92.5(EMS) MODE 1: 4.6(EMS) MODE 2: 4.8	No significant differences would raiseconcern in safety or effectiveness frompredicate deviceNOTE: Referring to "Maximum PhaseCharge" for details
	Frequency (Hz)	6~45	1 to 150	100	(TENS) MODE 3: 1.28(TENS) MODE 4: 1~59.8(EMS) MODE 1: 52.3(EMS) MODE 2: 5.8	No significant differences would raiseconcern in safety or effectiveness frompredicate device
	For Interferential Modes Only:Beat Frequency (Hz)	N/A	N/A	N/A	N/A	Identical
	Comparison item	Subject device	Predicate device #1	Predicate device #2	Reference device	SubstantialEquivalence Determination
Formultiphasic	Symmetricalphases?	N/A	N/A	N/A	YES	Identical to predicate device
waveformsonly:	Phase Duration	N/A	N/A	N/A	TENS & EMS : 100µS	Identical to predicate device
	Net Charge(µC per pulse @ 500Ω)	0	0	0	(TENS) MODE 3:9.7μC@500Ω(TENS) MODE 4:8.22μC@500Ω(EMS) MODE 1:7.5μC@500Ω(EMS) MODE 2:9.36μC@500Ω	Identical to predicate device
	Maximum Phase Charge(µC @ 500Ω)	21.6	45	7.2	(TENS) MODE 3:38.8μC@500Ω(TENS) MODE 4:32.88μC@500Ω(EMS) MODE 1:15μC@500Ω(EMS) MODE 2:37.44μC@500Ω	Predicate device #1 was used to indicatethat the Maximum Phase Charge of thesubject device is much lower thanPredicate device #1. The differenceswould not raise concern in safety oreffectiveness from predicate device
	Maximum Average Current(mA @ 500Ω)	9.04	13.5	10.182	(TENS) MODE 3:0.0124mA@500Ω(TENS) MODE 4:0.492mA@500Ω(EMS) MODE 1:0.393mA@500Ω(EMS) MODE 2:0.054mA@500Ω	No significant differences would raiseconcern in safety or effectiveness frompredicate device
	Electrode Conductive SurfaceArea (cm²)	53.2	20.25	28	N/A	Electrode Conductive Surface Area ofthe subject device is larger thanpredicate devices. If subject device hasthe same Electrode Conductive SurfaceArea like the predicated devices whichwill result in a smaller current densityand power density of the subject devicecompared to predicate devices #1 and#2, hence the differences would not raiseconcern in safety or effectiveness frompredicate device
	Maximum Current Density(mA/cm² @ 500Ω)	1.01	0.667	0.364	(TENS) MODE 3:8.08mA/cm²@500Ω(TENS) MODE 4:6.85mA/cm²@500Ω	No significant differences would raiseconcern in safety or effectiveness frompredicate device

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Traditional 510(k) Section 6 – 510(k) Summary

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Traditional 510(k) Section 6 – 510(k) Summary

Comparison item	Subject device	Predicate device #1	Predicate device #2	Reference device	SubstantialEquivalence Determination
				(EMS) MODE 1:6.31mA/cm²@500Ω(EMS) MODE 2:7.8mA/cm²@500Ω	Current density of the subject device islower than 2mA/cm² which meets therequirement of IEC 60601-2-10.
Maximum Power Density(W/cm² @ 500Ω)	0.055	0.0046	0.00185	(TENS) MODE 3:0.05W/cm²@ 500Ω(TENS) MODE 4:1.68W/cm²@ 500Ω(EMS) MODE 1:1.25W/cm²@ 500Ω(EMS) MODE 2:0.21W/cm²@ 500Ω	No significant differences would raiseconcern in safety or effectiveness frompredicate deviceMaximum Power Density < 0.25W/cm²
Remote communication mode?	RF: 2.4GHz transceiver	N/A	N/A	RF: 2.4GHz transceiver	Identical to ref. device
Wireless	FCC Part 15 ConductedEmissionsFCC Part 15 Radiated EmissionsFCC ID : 2A32IRFM-001	N/A	N/A	FCC Part 15 ConductedEmissionsFCC Part 15 RadiatedEmissionsRemote Control:FCC ID:2ACD4HD-5N-TXDevice: FCCID:2ACD4HD-5N-RX	Meets the same requirements as thereference device

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13. Similarity and Difference

Based on the comparison information in our submission, the indications for use of the subject device is similar to the predicate devices as all three devices provide a TENS mode for relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and lower extremities due to strain from exercise or normal household work activities. It also provides a heat function intended to temporarily relief minor aches and pains. The TENS and heat output parameters of the subject device is as safe and as effective as the predicate devices. The reference device is used to add wireless technology for remote control as all of the wireless specifications were based on the reference device.

14. Conclusion

After a series of non-clinical tests to ensure that our design outputs met the specified design inputs and needs of user, we believe that the subject device, Heating TENS (FT-810R), is substantially equivalent to the predicate device in safety and effectiveness.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).